Lystralin 25 mg Film-coated Tablets

It is important that treatment is started in early pro-oestrus, as soon as signs of pro-
oestrus are observed. If treatment is started close to ovulation or once ovulation has
occurred, treatment will not be efficacious.
Prior to treatment, pro-oestrus should be confirmed by a veterinary surgeon by
vaginoscopy, vaginal cytology or another suitable diagnostic method.
In laboratory and clinical studies used to evaluate the efficacy of the veterinary
medicinal product, pro-oestrus was defined as dogs having a
turgid/oedematous/plump vulva and sanguineous vulval discharge. On vaginoscopy,
the mucosal folds were pink-whitish, greatly enlarged, thickened, rounded,
oedematous/plump, and not dry. Vaginal cytology demonstrated predominantly
intermediate and superficial cells, alongside erythrocytes.
Bitches should not have contact with entire male dogs during the administration
period as data are not available on the effectiveness of the veterinary medicinal
product to suppress mating behaviour or reduce the risk of pregnancy before 7 days.
Treatment can result in a temporary increase in progesterone.
The veterinary medicinal product’s effects on mating and pregnancy rates following
the recommended use have only been evaluated as indirect consequences of its
primary effect on reproductive hormone kinetics. No information is available on the
direct effect the veterinary medicinal product may exert on oocyte maturation,
transport, fertilization and implantation.

Special precautions for safe use in the target species:
The overall systemic exposure, and associated safety margin, of the veterinary
medicinal product varies with the prandial status of the bitch (see Section 4.3
Pharmacokinetics). Therefore, the dosage instructions presented in Section 3.9
should be closely followed.
No data are available on the use of the veterinary medicinal product during a bitch’s
first heat. Therefore, the veterinary medicinal product is only recommended for use
in bitches from their second heat onwards.
The safety of the veterinary medicinal product has only been investigated in bitches
with normal mammary glands, and normal reproductive organs, confirmed on
ultrasound examination, prior to its administration.
The safety of repeated treatments, i.e., in more than one oestrus cycle, has not been
investigated.
The safety of the veterinary medicinal product has not been established in bitches
less than 10 months of age or weighing less than 2.6 kg.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Finrozole is a selective nonsteroidal aromatase enzyme inhibitor resulting in reduction
of oestrogen levels and prevention of follicle maturation.
Laboratory studies in rats have shown evidence of foetotoxic and teratogenic effects.
Pregnant women and those attempting to conceive should not administer this product.
If a broken tablet is rejected by the dog after chewing, it should be disposed of
carefully.
Accidental ingestion of this product may be harmful. Avoid ingestion of this product.
Any uneaten medicated food should be disposed of immediately and the bowl washed
thoroughly.
Keep the veterinary medicinal product in the outer packaging.
In case of accidental ingestion, seek medical advice immediately and show the
package leaflet or the label to the physician.
Wash hands thoroughly with soap and water following handling of the product.
Other precautions for the protection of the environment:
Not applicable.